Study Completed

Cardiovascular Agents

Bayer Identifier:

14769

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

To establish the bioequivalence between riociguat tablet 0.5 mg intended to be marketed (#501) and riociguat tablet 0.5 mg used for clinical samples (#511) in Japanese healthy adult male subjects.

Trial purpose

The study will be conducted in a single-center, randomized, non-blinded, two-way crossover study in Japanese healthy adult male subjects. 24 subjects will be selected among the subjects undergoing the screening examination conducted within 4 weeks before drug administration of period 1. Single oral doses of riociguat tablet 0.5 mg #501 and riociguat tablet 0.5 mg #511 will be given to selected 24 subjects under the fasting condition with a wash-out interval of 7 days or longer.
One day before the drug administration of each period the subjects will be admitted to the clinical site. During the hospitalization, blood samples for riociguat and its metabolite BAY 60-4552 (M-1) pharmacokinetics will be taken, and the subjects will undergo several tests for safety up to 72 hrs after the administration. Follow up examination will be conducted between Day 7 and Day 10 of period 2.

Key Participants Requirements

Sex

Male

Age

20 - 30 Years

Inclusion Criteria
- Japanese healthy male subjects, 20 and 30 years of age
- Normal body weight: BMI between 17.6 and 26.4 kg/m2
- Subjects who have been non-smoking for a period longer than 3 months
Exclusion Criteria
- A history of relevant diseases of internal organs (diseases that may significantly jeopardize body systems, such as severe liver or renal dysfunction, active peptic ulcer, ulcerative colitis, Crohn's disease, narrowing of colon lumen) or, of the central nervous system (eg epilepsy), of penile anatomical abnormalities (eg penile fibrosis or Peyronie disease), or other organs which are likely to show inappropriateness for participation in this study
- Conditions of such that would impair the subject’s ability to participate or complete this study in the opinion of the investigator (mental diseases that are thought to be ineligible for the communal life in the study participation, unable to consent to the participation, disables)
- Known drug hypersensitivity or idiosyncrasy
- Intake of habitual medication including Chinese herbal drugs
- Smoking within 3 months before the drug administration of period 1 and/or testing positive in Nicotine test at screening examination.
- Systolic blood pressure below 100 mmHg or 140 mmHg and over; Diastolic blood pressure 90 mmHg and over; Heart rate below 45/min or 90/min and over
- Relevant pathological findings in the 12-lead ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT/QTc-interval over 450 msec

Trial summary

Enrollment Goal

Trial Dates

August 2010 - September 2010

Phase

Phase 1

Could I Receive a placebo

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Osaka Pharmacology Clinical Research Hospital	Osaka, 532-0003, Japan

Primary Outcome

Bioequivalence between two tablet formulations of Riociguat assessed using AUC and C(max) calculated from plasma riociguat concentration
Time Frame:
up tp 72 hours
Safety Issue:
No

Trial design

Bioequivalence study of two tablet formulations of riociguat (BAY 63-2521) 0.5 mg – Randomized, non-blind, two-way crossover study to establish the bioequivalence between tablets intended to be marketed and clinical samples used in Phase III studies in Japanese healthy adult male subjects.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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